Statement: Senate HELP Committee Hearing on Supply Chain

“Biopharmaceutical research companies are committed to ensuring America’s patients receive safe and reliable medicines, which is why protecting and maintaining the security of the country’s prescription drug supply chain is a top priority.

The nation’s comprehensive drug regulatory system is critical to maintaining the high standards set by the Food and Drug Administration (FDA) for safety and efficacy and safeguarding against substandard or counterfeit medicines. To that end, manufacturers of pharmaceuticals sold legally in the U.S. must comply with FDA regulations, including FDA’s current Good Manufacturing Practice (cGMP) regulations. This systems-based approach lowers the risk that poor quality medicines reach the market by building quality directly into all stages of the manufacturing process.

Even with FDA’s regulatory system, increasing globalization of pharmaceutical supply chains requires the biopharmaceutical industry, Congress and the FDA to continually seek improvements to supply chain integrity. Today, PhRMA provided the U.S. Senate HELP Committee with preliminary suggestions, including:

Require all foreign establishments manufacturing prescription drug products or components destined for import into the U.S. to register with FDA and list their products, to the extent they are not already required to do so under law.

Grant the FDA discretion to set routine inspection intervals for foreign and domestic facilities according to risk.

Allow the FDA to maximize resources by relying on the inspection results of other foreign regulatory bodies with similarly robust drug regulatory oversight systems or to use accredited third parties to conduct some foreign inspections.

Consider the appropriateness of including new burdens on the import of materials for use in preclinical and clinical investigations. As this could be duplicative of existing requirements, we strongly encourage exempting these materials intended for clinical trials that already comply with other FDA requirements. This step could help ensure that new medicine development is not delayed or hindered.

“Supply chain security is of the utmost importance. That is why we are working with Congress and other stakeholders to discuss supply chain security options and strategies to improve what is already one of the most secure supply chains in the world.”